CLEAN ROOMS - Definition Federal Standard 209 definition: An enclose area that controls particulate count (viable and non-viable), humidity and temperature. - To meet the definition of a clean room, the extent of air cleanliness, the particulate count, can not exceed the class of cleanliness. Laminar flow hood and Biological Safety Cabinets can be considered mini-clean rooms by definition

ASEPTIC PROCESSING TECHNIQUE Definition: Techniques or processes used to prevent microbial contamination of an area and/or a product or a QC sample

CLEAN ROOM/CABINET ASEPTIC PROCESSING PRINCIPLES The room/cabinet is not a sterile environment Behavior within these environments need to be “controlled” to ensure product integrity is maintained

CLEAN ROOM/CABINET ASEPTIC PROCESSING PRINCIPLES Reduce bioburden of items brought into clean area prior to reaching the clean(est) area Do not contribute to bioburden of product during processing Particles that are released in the space can be flushed out by the air flow within the space

When possible cover your waste before carrying or pouring Handle waste after your critical processing steps have been performed

ASEPTIC PROCESSING SOLUTIONS Movement n In cabinet, don’t reach arms in and out n Once in clean room, stay there, if you can (utilized circulators) Quantity and Rate of Movement n Limit movement to necessary actions n Move slowly

Movement within Your Space

Avoid in-and-out movement of arms from hood Avoid movement in the clean room where you move from room to room

HORIZONTAL AIR FLOW CABINET PROCESSING SOLUTIONS Arrangement of items: - Items should be > 3 inches from most rear portion of cabinet - Items should be > 6 inches from front edge of cabinet - Large should not be placed towards the rear of the cabinet - Items should be arranged relative to cleanliness (you don’t want the dirtiest item placed upstream of your product).

Re-Examine as You Work Re-examine your workspace periodically Items should be > 3 inches from most rear portion of cabinet Avoid air exhaust obstruction

VERTICAL AIR FLOW PROCESSING SOLUTIONS Do not block air intakes on floor of cabinet Minimize equipment that blocks air intake in clean room

VENT OBSTRUCTION

Never place hands, supplies, drapes over air exhaust

LAMINAR HOOD – HORIZONTAL PROCESSING PRINCIPLES Do not interrupt pathways Strategically place equipment/supplies relative to upstream or downstream of each other

WHAT’s WRONG HERE?

Reorganize the equipment to avoid blocking air exhaust with large equipment

MINDFULL OF AIR STREAM

1. Vertical air flow: Hold syringe/hands to side of open tube 2. Minimize exposure of tube to large portion of the syringe

MAINTAIN STERILE ZONES Not all portions of the sterile-gowned individual are considered as sterile Only sterile area of body should be in contact with sterile fields

Maintain Sterile Zones Movement needs to be strategic with consideration of the sterile and non-sterile zones of the body When more than one person is in the space; walk back to back, rather than front to back Avoid leaning against sterile fields Face forward towards sterile field